• Ark Therapeutics Group plc, of London, said it signed an exclusive agreement to out-license the rights to its oxidized low density lipoprotein (Ox-LDL) auto-antibody diagnostic test kit (EG010) toLab21 Ltd., a UK diagnostics company. EG010 assesses the risk of people presenting with chest pain having had a heart attack. Data from a clinical trial of 121 patients showed the correlation between a positive test result and heart attack was 80 percent. Lab21 will conduct a further prospective clinical trial to investigate the additional predictive characteristics of EG010, take on the final automation and test optimization prior to launch and do sales and marketing. Ark is due a mix of up-front and milestone cash and future equity payments, together with a 5 percent royalty on future sales.

• Asterand plc, of Royston, UK, said the U.S. government awarded it a $2.9 million contract to assess the condition and value of the Department of Defense Armed Forces Institute of Pathology (AFIP) Tissue Repository, the largest tissue bank in the world that was established by President Lincoln in 1862. Currently there are records relating to approximately 7.5 million cases that span the period 1917 to the present, with more than 75 million associated samples. In 2005, it was decided to preserve the repository for future use in medical research and education, and characterize the collection. Asterand will report on the current state of the repository and make recommendations for best practices and use of this resource.

• Basilea Pharmaceutica Ltd., of Basel Switzerland, said Swissmedic has accepted for assessment the marketing authorization application of ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections. The application is subject to an accelerated review. The regulatory information was submitted by Basilea's license partner Janssen-Cilag AG, of Beerse, Belgium, a Johnson & Johnson company. Swissmedic previously granted accelerated assessment of the application. Ceftobiprole currently is under review by regulatory authorities in the U.S., Canada and the European Union.

• Bavarian Nordic, of Kvistgard, Denmark, said it received permission to invoice an advance payment of $50 million under the RFP-3 contract to manufacture 20 million doses of its Imvamune smallpox vaccine. In addition to the advance payment, the company expects to receive two further milestone payments of $25 million in 2007 for reaching other milestones.

• CellCentric Ltd., of Cambridge, UK, raised $4.3 million from Morningside Venture Investments Ltd.; Takeda Research Investment Inc.; the National Endowment for Sciences, Technology and the Arts; and Providence Investment Company Ltd. The funding should carry the company through to where it will be in a position to license out its cancer drug targets and epigenetic reprogramming screens.

• Eurofins Scientific, of Nantes, France, concluded an agreement with Lantmännen Invest AB, of Stockholm, Sweden, for the acquisition of its subsidiary, Lantmännen Analycen AB, which provides analytical testing services in various areas, such as agro-food products for both human and animal consumption, agronomic complements, pharmaceuticals and the environment. It operates in all Scandinavian countries, employing 400 people and earning annual revenues of about €40 million (US$56.36), but has been operating at a loss since the beginning of 2007. Eurofins said the takeover will consolidate its position as the leader of the foodstuff and environmental analytical testing market in Scandinavia.

• Genmab A/S, of Copenhagen, Denmark, said partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, filed a clinical trial application with British regulatory authorities for a Genmab antibody developed under the companies' collaboration, triggering an undisclosed milestone payment to Genmab. Under the agreement, Genmab uses its antibody development capabilities to create drugs against a broad range of disease targets identified by Roche in exchange for up to $100 million in milestone payments and potential royalties. In certain cases, Genmab might obtain rights to develop products emerging from the collaboration.

• Laboratorios Almirall SA, of Barcelona, Spain, entered a definitive agreement to acquire a portfolio of eight marketed products along with their associated European sales teams from Shire plc, of Cambridge, UK. Almirall will pay Shire $213 million for the products, which include Solaraze (diclofenac sodium 3 percent gel) for actinic keratosis, Vaniqa (11.5 percent eflornithine) for facial hirsutism, Lodine (etodolac) for rheumatoid arthritis, Colazide (balsalazide disodium) for ulcerative colitis, Cebutid (flurbiprofen) for rheumatoid arthritis, Meptid (meptazinol) for pain, Robaxin (methocarbamol) for muscle relaxation and Mintec (peppermint oil BP) for irritable bowel syndrome.

• MorphoSys AG, of Munich, Germany, has signed a research agreement with Genesis Research and Development Corp. Ltd., of Auckland, New Zealand, in which Genesis will continue to use MorphoSys' HuCAL-based antibodies against the human fibroblast growth factor receptor 5 (FGFR5) for target validation and preclinical studies as part of its proprietary Zyrogen program. Financial details of the deal were not disclosed. Genesis is investigating the development of therapeutic antibodies specific for the target molecule FGFR5, which is implicated in various autoimmune and bone-related diseases. Based on the scientific data generated by Genesis during the collaboration, the parties will discuss further development of the therapeutic program.

• Orexo AB, of Stockholm, Sweden, said it is developing a new, oral drug delivery technology using bioceramics developed by its Swedish partner Doxa AB. This delivery technology will provide a controlled release of the active substance and also has the potential to lessen the risk of abuse of the pain medication. The technology offers unique advantages and will provide for a new innovative platform for opioids, among others. Studies performed by Orexo indicated that the new drug delivery technology might offer considerable potential in this area of unmet need. Orexo also is developing a formulation of OX23, a highly potent substance for the treatment of moderate to severe acute pain. OX23 will be based on Orexo's sublingual tablet technology, combining fast-dissolving properties with rapid onset of action and predictable effect.

• Palau Pharma SA, of Barcelona, Spain, announced the formation of its scientific advisory board of six international experts in autoimmune and inflammatory diseases. The board will be chaired by Roderick Flower, a Fellow of the Royal Society, UK, and of the William Harvey Research Institute, School of Medicine and Dentistry, UK. Palau was formed in 2006 as a spinout from Spanish pharmaceutical company Grupo Uriach, raising €40 million. The company's pipeline consists of 10 compounds for diseases including asthma, psoriasis, IBD, RA, atopic dermatitis and organ transplant.

• Phosphagenics Ltd., of Melbourne, Australia, and Nestle Nutrition, of Vevey, Switzerland, said they will jointly start a Phase II trial in Australia shortly to establish the efficacy of Phosphagenics' Phospha E in the management of metabolic syndrome. Nestle will fund the trials and will be granted a worldwide exclusive license for the use of Phospha E in medical foods, while Phosphagenics will manufacture and supply the compound to Nestle. Final commercial arrangements are expected to be completed by the end of this year. Phospha E is a patented derivative of vitamin E, said to have superior properties compared to its parent molecule.

• Plethora Solutions Holdings, of London, announced further results and analysis of a Phase II clinical study of PSD597 in the treatment of interstitial cystitis and painful bladder syndrome, confirming and extending the initial positive outcomes announced Sept. 6. Patients who received PSD597 showed clear and substantial improvements in the primary endpoint measure, a patient-rated scale of improvement in bladder symptoms. The effect was confirmed in an extension to the study, which 86 percent of patients elected to take part in.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, said it intends to sell 3,726,708 shares of common stock in an underwritten public offering. Shares have not yet been priced. In addition, Protalix plans to grant underwriters a 30-day overallotment option to purchase a number of shares equal to 15 percent of the aggregate number of shares sold in the initial offering. The company is seeking to raise approximately $130 million. UBS Securities LLC is acting as sole book-running manager for this offering and CIBC World Markets Corp. is acting as a co-manager. Protalix has initiated enrollment and treatment of patients in its pivotal Phase III clinical trial of its lead product candidate, prGCD, for enzyme replacement therapy of Gaucher disease.

• PSivida Ltd., of Perth, Australia, said its financial statements for the fiscal year ended June 30 contain a going concern qualification from its independent accounting firm due to recurring losses and negative cash flows from operations. pSivida said it has sufficient cash to sustain operations through at least June 30, 2008.

• Serentis, of Cambridge, UK, has completed the acquisition of Surface Therapeutics Ltd., of Abingdon, UK, for the issue of shares in Serentis. Financial details were not disclosed. Surface was founded in 2004 as a spinout from the University of Oxford based on research by its two founders, William Cookson and Miriam Moffatt. Their research identified several genes that predispose an individual to atopic dermatitis and asthma. The company's lead product, a treatment for atopic dermatitis, is in late-stage preclinical evaluation.

• Summit Corp. plc, of Abingdon, UK, said that it has received £220,000 from the UK muscular dystrophy charity Parent Project UK. The funds will support Summit's preclinical Duchenne muscular dystrophy program and an early-stage research project called the ZF Partnership that is seeking to identify additional DMD therapies using zebrafish disease models.

• Trinity Biotech plc, of Dublin, Ireland, said its shareholders voted Oct. 1 to delist the company from the Irish Stock Exchange. The firm said it notified the exchange of its decision, which is anticipated to take effect on Nov. 5. The decision, the company said, will have no effect on its Nasdaq listing, of which 98 percent of all trading in the firm's shares takes place. Trinity Biotech develops, acquires, manufactures and markets diagnostic products used to detect sexually-transmitted and other infectious diseases, blood-coagulation disorders and autoimmune diseases.